A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HRS-9231 Injection in a Single Dose in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events, serious adverse events
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 45 years.
- •Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- •Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
排除标准
- •Patients with contraindications for magnetic resonance imaging (MRI) examinations.
- •During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
- •Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
- •Unable to tolerate venipunctures or have a history of fainting needles and blood.
- •People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)
研究组 & 干预措施
Group 1
8 healthy subjects were to be included
干预措施: HRS-9231 (Drug)
Group 1
8 healthy subjects were to be included
干预措施: Placebo (Drug)
Group 2
8 healthy subjects were to be included
干预措施: HRS-9231 (Drug)
Group 2
8 healthy subjects were to be included
干预措施: Placebo (Drug)
Group 3
8 healthy subjects were to be included
干预措施: HRS-9231 (Drug)
Group 3
8 healthy subjects were to be included
干预措施: Placebo (Drug)
Group 4
8 healthy subjects were to be included
干预措施: HRS-9231 (Drug)
Group 4
8 healthy subjects were to be included
干预措施: Placebo (Drug)
Group 5
8 healthy subjects were to be included
干预措施: HRS-9231 (Drug)
Group 5
8 healthy subjects were to be included
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events, serious adverse events
时间窗: From ICF signing date to Day10
次要结局
- Cl = total clearance(From baseline (1 hour before injection) to 12 hours post-injection)
- Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration(From baseline (1 hour before injection) to 12 hours post-injection)
- t1/2 = terminal elimination half-life of the compound(From baseline (1 hour before injection) to 12 hours post-injection)